Continuous Versus Intermittent cARdiac Electrical moNitorinG

Long QT Syndrome Clinical Trial

— CARING  

Official title:

Continuous Versus Intermittent cARdiac Electrical moNitorinG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336644
• Other study ID #: 202001147
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Joshua D Mitchell, M.D., FACC
• Phone: 314-494-3124
• Email: jdmitchell[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL) and being initiated on standard of care arsenic trioxide OR Diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) OR Diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment)
• At least 18 years of age.
• No allergy to adhesive patches.
• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

• Younger than 18 years of age
• Allergy to adhesive patches

Related Conditions & MeSH terms

• Long QT Syndrome
• Torsades de Pointe Caused by Drug
• Torsades de Pointes

Intervention

Device:
• BodyGuardian Mini Plus
The BodyGuardian Mini Plus attaches to the upper chest of the patient through the use of an adhesive patch. ECG tracings are recorded continuously and sent to the linked smartphone and subsequently to a cloud server.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot	The Bland Altman plot provides a graphical method to compare the question of interest, namely that the measurements derived from the patch monitor are accurate in relation to the gold standard of the ECG.; Each QT measured from the tracing will be plotted against the difference in QT between the tracing and the 12-lead ECG. The acceptable difference between measurement techniques will be set at 5 ms (primary, strict threshold based on FDA recommendations) with a clinically acceptable difference of 15 ms (based on known variability in 12-lead ECG recordings).	Through Day 30
Primary	Frequency of major arrhythmia occurrence	The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter	Through Day 30
Primary	Trajectories of QT prolongation	Will assess the QT interval every four hours for five days after drug initiation and after five days, the QTc will be assessed every 8 hours; With this data, the investigators will plot the QTc interval (Fridericia correction) over time and determine the time of expected peak effect. Outliers will be reviewed and verified manually.	Through day 30

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine